A Pilot Study of Creative Arts Interventions for Neurology Inpatients

Epilepsy Clinical Trial

Official title:

A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520777
• Other study ID #: 30498
• Status: Completed
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the feasibility of a Creative Artists Program intervention with epilepsy and headache patients admitted to Dartmouth-Hitchcock Medical Center for care by the Department of Neurology.

Description:

Qualifying patients admitted to Epilepsy monitoring or Headache treatment will be approached for participation in the study. Patients who consent to the study will be given a chance to work with one of three creative artists (visual artist, creative writer, therapeutic musician). The artist will be selected according to a pre-determined schedule, and the arts intervention may last up to 90 minutes. Subjects will be asked to complete study questionnaires before and after the arts intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > or = 18 years

2. Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache

3. Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service

4. Capable of giving informed consent

Exclusion Criteria:

1. Active psychiatric illness that prohibits safe visitation by artists

2. Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.

3. Active general medical condition that would impair consciousness.

Related Conditions & MeSH terms

• Epilepsy
• Migraine

Intervention

Other:
• Art Intervention
Type of artist intervention will be determined by the subject and the assigned artist.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of conducting a creative arts intervention study	The feasibility of the creative intervention will be determined by the completion rates of the initial intervention attempts. If less than 50% of patients complete the intervention it will be deemed unfeasible in the current format.	Through study completion, approximately 1 year
Secondary	Change in patient anxiety before and after the intervention	Change in anxiety level will be calculated, based on patient questionnaire responses, following the creative intervention.	Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
Secondary	Change in patient distress before and after the intervention	Change in distress level will be calculated, based on patient questionnaire responses, following the creative intervention.	Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
Secondary	Change in patient depression before and after the intervention	Change in depression level will be calculated, based on patient questionnaire responses, following the creative intervention.	Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
Secondary	Change in frequency of as-needed pain medication use	As-needed pain medication utilization will be evaluated following the creative arts intervention through subject discharge.	Each patient as-needed medication use will be assessed after the arts intervention and until discharge from the hospital (approximately Day 3 - 21).
Secondary	Length of hospital stay	Length of hospital stay will be calculated.	Each patient's admission duration (approximately 3 - 21 Days).